Shanghai Pharma Biotherapeutics USA Inc. (SPHBio; www.sphbio.com) is a wholly owned subsidiary of Shanghai Pharmaceuticals Holding Co. Ltd. (SPH; www.sphchina.com), one of the largest pharmaceutical companies in China. SPH has developed and delivered healthcare solutions and effective medicines to patients in China for the past century. SPH is committed to continuously bringing innovative medicines to patients that alleviate or cure diseases. SPHBio’s mission is to work with researchers, collaborators, and investors to identify and advance biopharmaceutical innovations that address unmet medical needs.
Director/Senior Director, Clinical and Regulatory Project Management
The Director/Senior Director, Clinical and Regulatory Project Management is responsible for the management of timelines and deliverables across all company programs and projects. The Director/Senior Director will work with both internal and external development teams. The individual is expected to be able to function independently in the daily management of research projects. The Director/Senior Director is responsible for providing leadership timely project updates and working closely with other functional areas. The Director/Senior Director will be a key contributor to clinical, regulatory and business development activities.
Job Location: San Diego, CA
Responsibilities:
Manage timelines and clinical operation activities in cooperation with the clinical group (e.g., CRO hiring and management, trial management, site monitoring, vendor management, TMF, data operations, IMP management, etc.) for one or more clinical programs.
Assist in the development and implementation of clinical project plans in accordance with corporate and regulatory objectives
Contribute to key study documents in conjunction with other team leads (e.g., protocols and informed consents, project plans and timelines, study reports, etc.)
Manage clinical trial resources and projections, including hiring plans and external budgets
Maintain an inspection readiness state throughout the lifecycle of development programs
Proactively identify, resolve and escalate issues that may jeopardize project completion on time or within budget
Contribute to global regulatory submissions
Communicate updates to senior leadership
Assist in the development of departmental SOP’s and compliance
Required Background:
Bachelor’s degree from an accredited institution, in a science- or health-related field
10 - 15 years of regulatory experience in the CRO, pharmaceutical, or biotechnology industry
3-5 years supervisory/management experience
Demonstrated experience in project management from initiation through completion
Clear understanding of the drug development process with experience in multiple phases in various therapeutic areas
Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously
Results-oriented with a keen attention to detail
Energy and drive to succeed in a high-paced start-up environment
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